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Gut Microbiota Reconstruction for the Treatment of Diarrhea-predominant Irritable Bowel Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT02651740
First received: January 6, 2016
Last updated: January 8, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to evaluate the efficacy as well as safety of rifaximin and fecal microbiota transplantation in the treatment of IBS-D.

Condition Intervention Phase
Irritable Bowel Syndrome
Drug: placebo
Drug: Rifaximin
Procedure: infusing saline through enteral nutrition tube
Procedure: FMT with donor stool through enteral nutrition tube
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gut Microbiota Reconstruction for the Treatment of Diarrhea-predominant Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • Number of patients with relief of IBS core symptoms ( abdominal pain and stool consistency ) [ Time Frame: 4 weeks after the treatment ]
    The proportion of patients who have relief of abdominal pain (daily assessed according to 0-10 point scoring system, with 0 indicating no pain at all and 10 indicating very great deal of pain, patients record the most severe pain in a day) and stool consistency (according to Bristol type) during the 4 weeks after the treatment.


Secondary Outcome Measures:
  • Number of patients with relief of other specific IBS symptoms besides abdominal pain and stool consistency ( including global IBS symptoms, stool frequency and IBS-related bloating ) [ Time Frame: 4 weeks after the treatment ]
    The proportion of patients who have relief of global IBS symptoms、 stool frequency、IBS-related bloating during the 4 weeks after the treatment.

  • Number of patients with relief of any IBS-related syptoms( including global IBS symptoms, abdominal pain, bloating, stool consistency and frequency ) [ Time Frame: 12 weeks after the treatment ]
    The proportion of patients who have relief of global IBS symptoms、abdominal pain/bloating/stool consistency/stool frequency during the 12 weeks after the treatment.

  • Number of patients with improvement of quality of life [ Time Frame: 4/12/24 weeks after the treatment ]
    The improvement of quality of life is measured by SF36-V2 and EQ-5D


Other Outcome Measures:
  • The rate and type of adverse effects [ Time Frame: The last day of the treatment and 4/8/12/24 weeks after the treatment ]
    It means any events that occur in the trial process related or unrelated to the drug/FMT that do harm to the patients' health, including symptoms/physical signs/abnormal lab values


Estimated Enrollment: 200
Study Start Date: December 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
taking placebo and then infusing saline through enteral nutrition tube
Drug: placebo
200mg tid* 3d
Other Name: vitamin C
Procedure: infusing saline through enteral nutrition tube
250ml per time for at least once
Experimental: Rifaximin
taking rifaximin and then infusing saline through enteral nutrition tube
Drug: Rifaximin
200mg tid* 3d
Other Name: Brand name: XIFAXAN; Production company: SALIX PHARMS
Procedure: infusing saline through enteral nutrition tube
250ml per time for at least once
Experimental: Fecal Microbiota Transplantation
taking placebo and then FMT with donor stool through enteral nutrition tube
Drug: placebo
200mg tid* 3d
Other Name: vitamin C
Procedure: FMT with donor stool through enteral nutrition tube
250ml per time for at least once
Experimental: Combined
taking rifaximin and then FMT with donor stool through enteral nutrition tube
Drug: Rifaximin
200mg tid* 3d
Other Name: Brand name: XIFAXAN; Production company: SALIX PHARMS
Procedure: FMT with donor stool through enteral nutrition tube
250ml per time for at least once

Detailed Description:
For IBS-D patients, rifaximin and fecal microbiota transplantation are given separately or together in order to evaluate the efficacy and safety of these two therapies compared with placebo.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 65, no gender limitation;
  • Had received a diagnosis of IBS-D (as assessed according to the Rome III diagnosis criteria of IBS) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed;
  • Has current symptoms of IBS-D: ①Abdominal pain (rated the average daily amount of abdominal pain as a score of more than 3 on a 0-10 point scoring system in a week (with 0 indicating no pain at all and 10 for a very great deal of pain)); ② Stool consistency (rated the consistency of their stools of Bristol types 6/7 (loose or watery) at least once a day and at least 2 days in a week);
  • Can do follow-up at required time points and signed written informed consent before the study.

Exclusion Criteria:

  • Allergic to rifaximin;
  • Taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month;
  • Had infective diarrhea history or had taken antibiotics within the previous 14 days;
  • Patients with a history of inflammatory bowel disease ;
  • Previous abdominal surgery (other than cholecystectomy or appendectomy);
  • Human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs;
  • Unstable diabetes, hypertension, thyroid disease, etc;
  • Accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases;
  • Accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc;
  • Other conditions that doctor thought not suitable for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02651740

Contacts
Contact: Shengdi Wu (86)13817923359 wu.shengdi@zs-hospital.sh.cn

Locations
China
Zhongshan Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Shengdi Wu    (86)13817923359    wu.shengdi@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
Study Chair: Xizhong Shen, PhD Zhongshan Hospital, Shanghai, China
  More Information

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02651740     History of Changes
Other Study ID Numbers: SXZ-WSD01-2015
Study First Received: January 6, 2016
Last Updated: January 8, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Shanghai Zhongshan Hospital:
Rifaximin
Fecal microbiota transplantation

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on March 28, 2017